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Contraception App Approved by FDA The approval of the app Natural Cycles marks the first time the U.S. Food and Drug Administration (FDA) has approved a birth control app marketed as a mode of contraception. Dr. Terri Cornelison, U.S. FDA, via ABC News Using a woman's daily body temperature data and menstrual cycle information, the app calculates the fertility of the user. Dr. Terri Cornelison, U.S. FDA, via ABC News According to the FDA, in clinical studies involving more than 15,000 women, the app had a

FDA approves first-ever contraception app

The app, Natural Cycles, calculates when a woman is most likely to be fertile.

The Natural Cycles app from Natural Cycles Nordic AB, approved in Europe last year, helps calculate the days of the month a woman is most likely to be fertile. Its algorithm uses data based on daily body temperature readings and menstrual cycle information and then tells women when to abstain from sex (less fertile) or use protection (more fertile).

This type of contraception method, according to the FDA, is known as fertility awareness.

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“Our app will analyse your cycle and tell you exactly when you need to use protection or can enjoy more sexual freedom with your loved one,” Natural Cycles wrote on its product website, warning that the app doesn’t protect against sexually-transmitted infections.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in the agency announcement. “But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device.”

Effectiveness of Natural Cycles

According to the FDA, clinical studies showed the app had a “perfect use” failure rate of 1.8 percent, “which means 1.8 in 100 women who use the app for one year will become pregnant because they had sexual intercourse on a day when the app predicted they would not be fertile or because their contraceptive method failed when they had intercourse on a fertile day.”

Studies also showed a 6.5 percent “typical use” failure rate, taking into account women who are incorrectly using the app.

Natural Cycles costs $10 per month or $80 per year and currently boasts more than 620,000 users.

But according to Engadget, the app has received its share of criticism. In July, the United Kingdom’s Advertising Standards Authority launched an investigation into Natural Cycles Nordic AB over claims the company made in a Facebook ad describing the app as a “highly accurate contraception that has been clinically tested.”

“Many other apps focus on getting to know your own body, but Natural Cycles is specifically targeting itself as a contraceptive, which is concerning,” a spokesman for the U.K. Family Planning Association told The Guardian.